Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti
FDA premarket approval P870024/S056 · decided 2020-08-31
Approval details
- PMA number
- P870024
- Supplement
- S056
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2020-08-04
- Decision date
- 2020-08-31
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Addition of a new DAC brand of lathe machines.
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